Thin film medical device and delivery system

Abstract

The present invention relates to a delivery system for an intraluminal thin film medical device particularly well suited for occlusion of an aneurysm, vessel side branch or dissection of a body lumen or duct, such as an artery or vein. The delivery system has an outer sheath attached along the distal end of a relatively long and flexible tubular shaft. The outer sheath is capable of constraining the thin film medical device in a longitudinally stretched position, and subsequently being retracted relative to the flexible tubular shaft to release the thin film medical device from the constrained longitudinally stretched position. The delivery system may additionally have a secondary sheath substantially coaxial too, and slideably engaged within, the outer sheath. The secondary sheath is capable of restraining a self-expanding support structure in a radially constrained position, and subsequently being retracted to release the self-expanding support structure from the radially constrained position. The delivery system also comprises an inner lumen substantially coaxial to the outer sheath and incorporated into the flexible tubular shaft.

1 . A delivery system for deploying a thin film medical device having a self-expanding radial support structure comprising: 
 an outer sheath attached along the distal end of a relatively long and flexible tubular shaft, the outer sheath being capable of constraining the thin film medical device in a longitudinally stretched position, and subsequently being retracted relative to the flexible tubular shaft to release the thin film medical device from the constrained longitudinally stretched position;    a secondary sheath substantially coaxial too, and, slideably engaged within, the outer sheath, the secondary sheath being capable of restraining the self expanding support structure in a radially constrained position, and subsequently being retracted to release the self expanding support structure from the radially constrained position; and    an inner lumen substantially coaxial to the outer sheath and incorporated into the flexible tubular shaft.    
   
   
       2 . The delivery system of  claim 1  wherein the outer sheath comprises a polymeric material.  
   
   
       3 . The delivery system of  claim 2  wherein the polymeric material comprises a polymer from the group consisting of polyethylene, polyamide, polyurethane, and polytetrafluroethylene.  
   
   
       4 . The delivery system of  claim 2  wherein the polymeric material comprises a polymer from the group consisting of polycarbonate and polyimide.  
   
   
       5 . The delivery system of  claim 1  wherein the outer sheath has reinforcement material.  
   
   
       6 . The delivery system of  claim 5  wherein the reinforcement material is a metallic braid integrated into the outer sheath.  
   
   
       7 . The delivery system of  claim 5  wherein the reinforcement material is a high tensile strength polymeric braid woven into the outer sheath.  
   
   
       8 . The delivery system of  claim 1  wherein the secondary sheath comprises a composite structure.  
   
   
       9 . The delivery system of  claim 8  wherein the composite structure includes an inner layer, an outer layer, and a middle layer.  
   
   
       10 . The delivery system of  claim 9  wherein the inner layer comprises polytetrafluoroethylene.  
   
   
       11 . The delivery system of  claim 9  wherein the outer layer comprises a polyamide.  
   
   
       12 . The delivery device of  claim 11  wherein the outer layer comprises a single outer polyamide layer extending from its proximal to its distal end.  
   
   
       13 . The delivery device of  claim 11  wherein the outer layer comprises a series of fused transition segments decreasing in material durometer from its proximal end to its distal end.  
   
   
       14 . The delivery device of  claim 9  wherein the middle layer comprises a radial support structure  
   
   
       15 . The delivery device of  claim 14  wherein the radial support structure comprises a braid layer.  
   
   
       16 . The delivery device of  claim 14  wherein the radial support structure comprises a coil.  
   
   
       17 . The delivery system of  claim 8  wherein the composite structure includes a proximal sheath, a distal sheath, and a distal end tube coaxially aligned end to end and fused to one another along a longitudinal axis.  
   
   
       18 . The delivery system of  claim 17  wherein the proximal sheath comprises stainless steel.  
   
   
       19 . The delivery system of  claim 17  wherein the distal sheath comprises a co-extruded substantially flexible material over a lubricous material.  
   
   
       20 . The delivery system of  claim 19  wherein the substantially flexible material comprises a nylon.  
   
   
       21 . The delivery system of  claim 19  wherein the lubricous material comprises a polymer.  
   
   
       22 . The delivery system of  claim 17  wherein the distal end tube comprises a co-extruded substantially flexible material over a lubricous material.  
   
   
       23 . The delivery system of  claim 1  wherein the inner lumen comprises a single layer polymeric material.  
   
   
       24 . The delivery system of  claim 23  wherein the inner lumen is coated with a lubricious coating.  
   
   
       25 . The delivery system of  claim 1  wherein the inner lumen comprises a multi-layered polymeric material.  
   
   
       26 . The delivery system of  claim 1  wherein the inner lumen comprises a reinforcement material.  
   
   
       27 . The delivery system of  claim 26  wherein the reinforcement material is a metallic braid integrated into the inner lumen.  
   
   
       28 . The delivery system of  claim 26  wherein the reinforcement material is a high tensile strength polymeric braid woven into the inner lumen.  
   
   
       29 . A delivery system for deploying a self-supporting thin film medical device in a body lumen comprising: 
 an outer sheath attached along the distal end of a relatively long and flexible tubular shaft, the outer sheath being capable of constraining the thin film medical device in a longitudinally stretched position, and subsequently being retracted relative to the flexible tubular shaft to release the thin film medical device from the constrained longitudinally stretched position; and    an inner lumen substantially coaxial to the outer sheath and incorporated into the flexible tubular shaft.    
   
   
       30 . A delivery system for deploying a thin film medical device having a radially expandable support structure comprising: 
 an outer sheath attached along the distal end of a relatively long and flexible tubular shaft, the outer sheath being capable of constraining the thin film medical device in a longitudinally stretched position, and subsequently being retracted relative to the flexible tubular shaft to release the thin film medical device from the constrained longitudinally stretched position;    a mechanical expansion catheter substantially coaxial too, and slideably engaged within, the outer sheath, the mechanical expansion catheter being capable of radially expanding the expandable support structure; and    an inner lumen substantially coaxial to the outer sheath and incorporated into the flexible tubular shaft.